Senior Regulatory Affairs Associate – FSP

Parexel

. Provide post-authorization lifecycle management .

Posted 11/5/2026full-timeRemote • AustraliaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates strong expertise in post-authorization lifecycle management and regulatory compliance, with a focus on local health authority interactions and documentation. Proven ability to manage projects, collaborate with cross-functional teams, and communicate effectively in both local and English languages.

Highest-signal resume keywords

Post-Authorization Lifecycle ManagementRegulatory ComplianceHealth Authority ManagementProject ManagementClient-Focused Approach

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory RequirementsDocument Management ToolsImpact AssessmentsVariations and RenewalsPSURsModule 1 DocumentationTechnical Change ManagementLocal Legislation ComplianceIntercultural CommunicationCritical Thinking

Soft Skills

TeamworkCollaborationResults OrientationProblem-SolvingExcellent Communication

Certifications & Qualifications

Bachelor's Degree in Scientific or Technical Discipline

Industry Keywords

AustraliaNew ZealandGlobal Regulatory TeamsLocal Regulatory GuidelinesHealth Authority InspectionsClient Relationship ManagementIndustry RelationshipsConsulting ServicesProject ScopingFinancial Reporting

About the role

Key responsibilities & impact

Provide post-authorization lifecycle management
Prepare, organize, and coordinate local-specific documentation to maintain regulatory compliance
Support health authority inspections as needed
Manage variations, renewals, PSURs, label updates, and CMC changes
Manage health authority interactions and responses to questions
Use internal document management tools and external platforms
Coordinate impact assessments for technical changes affecting marketing authorization
Work with medical, marketing, manufacturing sites, and other non-regulatory stakeholders
Monitor local regulatory requirements and guidelines and communicate requirements to GRA and other team members
Participate in regulatory meetings and share insights and best practices
Work independently and within a team environment to deliver project services
Prioritize work and complete assigned project activities within project guidelines
Produce quality work meeting project lead and client expectations
Potentially lead small-scale projects or workstreams on larger projects
Plan and set up projects; coordinate forecasting, financial entries, invoicing, reporting, training compliance, risk escalation, and close-out activities
Serve as the main client contact and ensure accurate project reporting
Identify change-in-scope and add-on business opportunities
Deliver consulting services within area of expertise
Identify project and client needs and propose solutions with senior staff
Support presentations, project scoping calls, and proposal preparation
Build industry relationships and communicate potential business leads
Complete timesheets, expense reports, CV maintenance, training compliance, deliverable archiving, and internal initiatives
Maintain relevant industry or scientific/technical association membership and define self-development activities

Requirements

What you’ll need

Strong knowledge and hands-on experience in Australia and New Zealand
Previous experience working in industry in support of Global and/or local Regulatory teams
Comprehensive understanding of regional and global regulatory requirements, guidelines and processes
In-depth expertise on local health authority management
Strong knowledge of post-authorization lifecycle maintenance procedures, including variations, renewals, and PSURs
Experience managing health authority interactions and responses to questions
Experience using document management tools and external platforms
Ability to prepare, organize, and coordinate local-specific documentation, including Module 1
Ability to maintain national systems according to local legislation
Ability to manage or coordinate impact assessments for technical changes affecting marketing authorization
Ability to work with medical, marketing, manufacturing, and other non-regulatory stakeholders
Knowledge of local regulatory requirements and guidelines
Project management knowledge
Client-focused approach to work
Results orientation
Teamwork and collaboration skills
Excellent written and verbal interpersonal and intercultural communication skills
Critical thinking and problem-solving skills
Proficiency in the local language and extensive working knowledge of English
More than 4–5+ years of experience in an industry-related environment in Australia, including New Zealand
Minimum of a Bachelor's Degree in a Scientific or Technical Discipline